Your single source to navigate the regulatory landscape and drive strategic decisions.

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Staying current with the ever-changing regulatory landscape is challenging. New changes emerge almost every day, and a lack of harmonization across all the regions you work in only adds to the complexity. If you’re not referencing the most recent guidance documents, you may be introducing unnecessary compliance risks, including citations, fines, and failed submissions – ultimately wasting time, money and resources.

We’ve removed the hard work of finding, integrating and analyzing regulatory information so you can focus on the critical decisions needed to get your products to market faster. Access Cortellis Regulatory Intelligence™ to get comprehensive, global, and expertly-analyzed information that spans all regulatory functions across the R&D lifecycle – all in one central location. With Cortellis as part of your standard workflow, you can confidently comply with regulatory guidelines, increase submission approval rates, and successfully launch in markets worldwide.

Maintain compliance, increase approval rates and expand to new markets.

Daily updates

Monitor regulatory changes using comparison tables that are continuously updated and linked to regulatory source documents, such as FDA483s, approval documents, inspection reports, and submission forms. And, download our mobile app to get the latest updates sent to your smartphone.

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"Since I have Cortellis Regulatory Intelligence, I can find out the updates faster than waiting for the licensee notices."

Talia Gaeta

Senior Regulatory Affairs Analyst Biosidus S.A.,
Argentina

Detailed summaries

Efficiently compare regulatory requirements across countries with detailed summaries of local regulatory practices and reference documents in English, translated by regulatory professionals who are also native language speakers.

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"The global regulatory comparisons are very useful to compare specific issues between regions."

Talia Gaeta

Senior Regulatory Affairs Analyst Biosidus S.A.,
Argentina

Proprietary reports

Prepare for inspections, monitor drug approval trends and maintain compliance with GXP and drug safety reporting requirements using searching inspection documents and proprietary regulatory intelligence reports – all manually curated by our editorial team.

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"Cortellis Regulatory Intelligence allows us to have a cross-checking system… and to work in regulatory strategy in countries where commercial markets exist with no defined partners."

Talia Gaeta

Senior Regulatory Affairs Analyst Biosidus S.A.,
Argentina

Full coverage

Conduct pre- and post-marketing surveillance, stay compliant, and understand approvals using comprehensive coverage of FDA AdComm meetings and workshops.

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"Cortellis Regulatory Intelligence allows us to have a cross-checking system in place and to work on regulatory strategy in countries where commercial markets exist with no defined partners."

Talia Gaeta

Senior Regulatory Affairs Analyst Biosidus S.A.,
Argentina

Consulting services

Clarivate experts bring together a unique combination of Cortellis content (and other available data sources) with experienced consultants and proprietary methodologies to drive life sciences innovation faster. Get independent objectivity, for better results. Our experts bring you unrivaled data science expertise, evidence-based consulting, and independent advice across the pharmaceutical R&D value chain.

 

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Get one-click access to unlock hidden insights in data.

Global coverage of drug and biologic regulatory information.

Comprehensive source of global regulatory information for medical devices and IVDs.

Get the latest updates via customized alerts sent to your smartphone with our mobile app.

Prepare for inspections, understand trends in drug approvals, discern submission requirements and instructions, and much more.

Avoid the need to access multiple regulatory authority websites to understand which fit best with your strategy by quickly comparing regulations across countries.

Quickly understand regulatory requirements across all aspects of therapy development.

Unravel the complexities of regulatory pathways through a single, reliable source.

200 K+

Regulatory documents for drugs, biologics, medical devices, and IVDs

80

Countries and regions

2.4 K+

Regulatory summaries

7 K+

Regulatory intelligence reports

1.6 K+

Exclusive English translations

5 K+

Inspection documents

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Our accredited global alliance program delivers value-added solutions by combining offerings from Clarivate with other technology and service providers. Partner with us to drive profitable growth, increase revenue and deliver greater value to your customers.

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Contact us to schedule a demo of Cortellis Regulatory Intelligence.

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